Aims:
Cardiovascular fixed-dose combination (FDC) pills, or polypills, may help address the large treatment gaps that exist among patients with cardiovascular disease or similarly high risk. Initiation of polypill-based care in this group typically entails switching from current separately taken medications. Given the heterogeneity in usual care, there is interest in the impact of polypill treatment across different prior medication regimens.
Methods:
This abstract describes effects of a polypill-based treatment strategy, according to baseline anti platelet, statin and blood pressure (BP)-lowering therapy, in a randomized clinical trial among 2004 participants from India and Europe. The main eligibility criteria were established cardiovascular disease or estimated five year cardiovascular risk of ≥15%. Participants were randomly assigned to a polypill-based treatment strategy or usual care. In the polypill group, physicians could use a polypill that contained aspirin 75 mg, simvastatin 40 mg, lisinopril 10 mg and either atenolol 50 mg or hydrochlorothiazide 12.5 mg. Baseline medication was reviewed and coded into categories. Statin therapy was defined as less potent than the polypill if estimated LDL-cholesterol reduction was 40%. Estimated cardiovascular risk reduction was calculated by combining risk factor changes with results seen in meta-analyses of previous randomized trials.
Results:
The effect of the polypill at twelve months was relatable to baseline statin usage, with LDL differences of -0.37, -0.22, -0.14 and -0.07 mmol/L compared to continuing usual care among patients taking no statin, less potent, equipotent and more potent statin at baseline, respectively. Similarly there were differences in systolic BP of -5.4, -6.2, -3.3 and -1.8 mmHg among patients taking 0, 1, 2 or ≥3 BP-lowering agents. Among patients taking more potent statins at baseline, there was no significant difference in LDL-cholesterol but there were benefits for BP and aspirin adherence. Similarly, among patients taking ≥3 BP-lowering agents, there were no differences in BP, but benefits for LDL-cholesterol and aspirin adherence. As a result, there were estimated cardiovascular relative risk reductions across all subgroups defined by baseline medication usage.
Conclusion:
Adherence benefits from switching to a polypill resulted in risk factor changes that were at least as good as usual care, even when usual care involved more potent regimens. More importantly, switching to a polypill-based strategy resulted in estimated cardiovascular relative risk reductions across a wide range of usual care patterns of antiplatelet, statin and BP-lowering therapy prescribing.
Fixed-dose combination therapy for the prevention of cardiovascular disease
